Cohort Event Monitoring Study of Pyramax®

Malaria,Falciparum Clinical Trial

Official title:

Phase IIIb/IV Cohort Event Monitoring Study To Evaluate, In Real Life Setting, The Safety And Tolerability In Malaria Patients Of The Fixed-Dose Artemisinin-Based Combination Therapy Pyramax®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201770
• Other study ID #: SP-C-021-15
• Status: Completed
• Phase: Phase 4
• Start date: June 22, 2017
• Est. completion date: April 10, 2019

Study information

• Verified date: January 2018
• Source: Shin Poong Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is to be performed in public health facilities in Central and West Africa where Pyramax will be used as treatment of uncomplicated malaria episodes, including repeat episodes. The study is to assess the safety of Pyramax, particularly in patients with underlying liver function abnormalities, in patients who have co-morbid conditions, such as HIV, and also in very small children (<1 year of age).

Description:

This is a non-comparative Cohort Event Monitoring study. The study will assess the safety of Pyramax in terms of the evaluation and identification of the hepatic safety events in a sub group of patients enrolled with liver function tests (LFT)s >2x upper limit of normal (ULN) from blood taken immediately prior to treatment without any clinical signs or symptoms of hepatotoxicity and with signs and symptoms of uncomplicated malaria confirmed by a Rapid Diagnostic Test (RDT) or microscopy (thick blood smear). The study will compare the clinical hepatic safety of Pyramax between a cohort of patients enrolled with LFTs >2xULN and a cohort of patients enrolled with normal LFTs matched for demographic characteristics.

An estimated 8,572 malaria episodes are to be recruited to provide 120 malaria episodes in patients with baseline raised LFTs >2xULN for follow up of liver function. A cohort of at least 2% of children who are <1 year of age will be included for monitoring of liver function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8572
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months and older

Eligibility

Inclusion Criteria:

• Uncomplicated malaria (Plasmodia of any species) diagnosed as per national policies and in line with WHO recommendations:

• Fever or history of fever in the previous 24 h and/or the presence of anaemia, for which pallor of the palms appears to be the most reliable sign in young children.

• Confirmation of malaria by a parasitological diagnosis (RDT or Microscopy (thick blood smear). analysis).

• Weight =5 kg - < 20 kg (granules); =20 kg (tablets).

• Ability to take an oral medication.

• Ability and willingness to participate based on signed informed consent (a parent or a guardian has to sign for children below 18 years old) and on signed assent form for minors that could be required per national regulations in each participating country.

• The patient has to comply with all scheduled follow-up visits.

Exclusion Criteria:

• Patients with clinical signs or symptoms of hepatic injury (such as nausea, abdominal pain associated with jaundice) or known severe liver disease (i.e. decompensated cirrhosis, Child-Pugh stage 3 or 4).

• Known allergy to artemisinin and/or to pyronaridine.

• Known pregnancy.

• Lactating women should be excluded if other anti-malarial treatments are available.

• Complicated malaria as per WHO definition (Annex 2)

• Patients that the investigator considers would be at particular risk if receiving an anti-malarial or if participating in the study.

• Patients having been treated with Pyramax in the previous 28 days.

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Malaria,Falciparum

Intervention

Drug:
• pyronaridine artesunate
Antimalarial treatment

Locations

Country	Name	City	State
Cameroon	The Biotechnology Center Nkolbisson, Univ of Yaounde I, Messa	Yaoundé
Congo	Centre de Santé FCRM, Hospital of Talangai	Brazzaville
Congo, The Democratic Republic of the	Centre de Recherche du Centre Hospitalier du Mont Amba	Kinshasa
Côte D'Ivoire	Institut Pierre Richet / Institut National de SanPublique (IPR/INSP)	Bouaké
Gabon	CERMEL, Albert Schweitzer Hospital	Lambaréné

Sponsors (2)

Lead Sponsor	Collaborator
Shin Poong Pharmaceutical Co. Ltd.	Medicines for Malaria Venture

Countries where clinical trial is conducted

Cameroon,  Congo,  Congo, The Democratic Republic of the,  Côte D'Ivoire,  Gabon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation and identification of hepatic safety events, including raised liver function tests	Evaluation and identification of hepatic safety events (including raised liver function tests - LFTs) of Pyramax in a sub group of malaria patients enrolled with LFTs >2xUL.	Assessment up to Day 28.
Secondary	Overall safety	Evaluation of the adverse event reporting of Pyramax in the treatment of uncomplicated malaria under real life conditions.	Assessment up to Day 28.
Secondary	Evaluation of Efficacy	Evaluation of the efficacy based on crude Day 28 cure rate by species and PCR adjusted cure rate for Day 28 cure rate for P. falciparum of Pyramax in the treatment of uncomplicated malaria under real life conditions	Assessment up to Day 28.